eligibility_summary
Adults (≥18) with WHO-defined MCL, ≥1 prior therapy (ibrutinib ≤4 wks ok if measurable, no progression), requires treatment, measurable disease, ECOG ≤2, adequate marrow, coagulation, renal (CrCl ≥30), and hepatic function. Contraception/negative pregnancy test, able to swallow, consent. Exclude: recent allo-SCT/GVHD, CNS MCL, autoimmune cytopenias, prior BTK/BCL2 or >4-wk ibrutinib, recent anti-cancer/steroid tx, strong CYP3A inhib/inducers, warfarin, antiretrovirals, grapefruit/Seville/star fruit, major CVD/stroke/ICH, other active cancers, active HBV/HCV/HIV/infection, live vaccine or major surgery <4 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, open-label, risk-stratified trial in relapsed/refractory mantle cell lymphoma. Standard-risk (no 9p21 loss, no SMARCA2/4 mut/del): ibrutinib + rituximab + venetoclax. High-risk (9p21 loss or SMARCA2/4 mut/del): adds navitoclax. Drugs/mechanisms: Ibrutinib (small-molecule covalent BTK inhibitor) blocks B-cell receptor signaling, Venetoclax (small-molecule BH3 mimetic) selectively inhibits BCL-2 to trigger mitochondrial apoptosis, Rituximab (anti-CD20 monoclonal antibody) depletes B cells via CDC/ADCC/apoptosis, Navitoclax (small-molecule BH3 mimetic) inhibits BCL-2/BCL-XL/BCL-W to overcome BCL-XL-mediated resistance. Targets/pathways: malignant B cells, BTK/BCR signaling, anti-apoptotic BCL-2 family (BCL-2, BCL-XL, BCL-W), CD20. High-risk biology linked to SWI/SNF (SMARCA2/4) mutations or 9p21 loss driving BCL-XL upregulation.